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MRI brain imaging in spontaneous intracerebral haemorrhage; pinpointing the underlying vascular disease

MRI brain imaging in spontaneous intracerebral haemorrhage; pinpointing the underlying vascular disease - FETCH: Finding the ETiology in spontaneous Cerebral Haemorrhage

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON44852
Enrollment
300
Registered
2013-08-12
Start date
2013-10-18
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

spontaneous intracerebral haemorrhage / brain bleeding

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: For substudy A - 3T unenhanced MRI scanning: - Age >= 18 years - ICH confirmed by CT - 3T MRI scanning possible preferably within 10 days, but at least within 3 months of ICH diagnosis - No obvious cause of ICH (tumor, vascular anomaly or trauma as cause of haemorrhage);For substudy B - 7T gadolinium enhanced MRI scanning: - Participants of substudy A - 7T MRI scanning possible preferably within 10 days, but at least within 3 months of ICH diagnosis;For substudy C - CT spot sign study: - Age >= 18 years - ICH confirmed by CT - CTP and CTA has been performed on admission - Non contrast CT possible within 48 hours after symptom onset. - No obvious cause of ICH (tumor, vascular anomaly or trauma as cause of haemorrhage)

Exclusion criteria

Exclusion criteria: For substudy A - 3T unenhanced MRI scanning: - Contraindications for MR imaging (see appendix A research protocol) ;For substudy B - 7T gadolinium enhanced MRI scanning: - Impossibility to undergo MRI (claustrophobia, implants or metal objects in or around the body). - Known prior allergic reaction to gadolinium contrast or one of the constituents of its solution for administration. - Severely impaired renal function (severe renal insufficiency, GFR

Design outcomes

Primary

MeasureTime frame
Number and distribution of markers for brain and vascular abnormalities and on Magnetic Resonance Imaging (MRI). Number and characteristics of CTA spot sign and haematoma growth.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)